Nuvasive Archives - Medical Design Sourcing

Analysts downgrade NuVasive stock

Needham analysts wrote today that they downgraded NuVasive (Nasdaq:NUVA) stock ahead of a potentially slow start to 2023.

Analysts Davis Saxon, Mike Matson and Joseph Conway contributed to the Needham report. They switched NuVasive from a “Buy” to a “Hold” rating.

The analysts explained their belief that NuVasive’s key launches “could begin to slow” in 2023. Compounded by an increase in competition, challenging NuVasive’s market leadership position, the stock may struggle.

Another wrinkle comes in the form of a $450 million debt refinancing. The analysts said it could result in a headwind greater than 8¢ to the company’s 2023 EPS.

“Given these points, we believe the 2023 consensus estimate leaves little room for upside, which is needed to drive multiple expansion, in our view,” the analysts wrote. “While valuation appears attractive, relative to our broader coverage we believe…

NuVasive reports mixed Q3 results, reduces guidance

NuVasive (Nasdaq:NUVA) reported third-quarter results that beat on EPS but missed on revenue, reducing its guidance amid macroeconomic headwinds.

Investors reacted to yesterday evening’s news by sending NUVA shares down more than 1% to 36.84 apiece in morning trading today. MassDevice‘s MedTech 100 Index, which includes stocks of the world’s largest medical device companies, was up more than 3%.

The San Diego–based spine tech company lost $1.98 million, or 4¢ per share, off revenue of $295.3 million for the quarter ended Sept. 30, 2022. Its losses were much reduced from the $21.64 million, or 42¢ per share, it lost in Q3 2021. In addition, revenue was up 9%.

Adjusted to exclude one-time items, NuVasive had EPS of 54¢. The 54¢ was in-line with Wall Street expectations. However, analysts on average had expected $298.75 million in revenue.

“The strategic investments we’ve made in product and technology innovation are delivering con…

Former NuVasive executive takes corner office at LimaCorporate

LimaCorporate CEO Massimo Calafiore

LimaCorporate announced today that its board of directors appointed former NuVasive executive Massimo Calafiore as its new CEO.

Calafiore resigned as NuVasive’s chief commercial officer last month. He also served as an EVP at the orthopedic device company before his departure.

Before serving as EVP and CCO, Calafiore oversaw NuVasive’s product marketing and commercial functions. He also held responsibility for the company’s business units, including specialized orthopedics and clinical services. Calafiore now brings more than 20 years of experience in the orthopedic field to the corner office at LimaCorporate.

“I am honored to take on this role as CEO of LimaCorporate. Thanks to our internal talent, know-how, and industry-leading R&D capabilities, I will continue to focus on positioning the company as a global leader in advanced orthopedic solutions,” Calafiore said in a news release. …

Nuvasive chief commercial officer Massimo Calafiore is stepping down

Nuvasive this week announced chief commercial officer Massimo Calafiore is resigning, effective August 31.

Upon his resignation, Calafiore’s responsibilities will be reallocated among the executive management team while the company aligns its commercial structure.

“On behalf of the NuVasive team, I would like to thank Massimo for his impact on our organization,” CEO Chris Barry said in a news release. “He has accomplished much during his tenure at NuVasive and we wish him great success in his new opportunity.”

Calfiore has been with the company since June 2017. Prior to that, he held numerous leadership roles at Waldemar Link.

“In my five years at NuVasive, I am very proud of our collective work to transform surgery, advance care and most importantly—change the lives of patients around the world. NuVasive is an amazing company, and I’m excited to see what it will accomplish through bringing world-class, innovative technology to market,” Cala…

Nuvasive lowers EPS guidance after mixed-bag Q2

Nuvasive (Nasdaq:NUVA) reported second-quarter results that beat the revenue consensus on Wall Street but missed earnings estimates.

The San Diego–based spine surgery tech company yesterday evening reported losses of $893,000, or 2¢ per share, on sales of $310.5 million for the three months ended June 30, 2022 — versus a profit of $1.799 million, or 3¢ per share, on sales of $294.8 million in Q2 2021.

Adjusted to exclude one-time items, earnings per share were 47¢, 9¢ behind The Street, where analysts were looking for sales of $306.62 million.

“We are encouraged by our top-line growth in the second quarter, driven by procedure volumes, new product introductions, and continued global execution of our growth strategies,” CEO Chris Barry said in a news release. “As surgeons look for differentiated technologies to enable more intelligent surgery, our C360 portfolio, X360 portfolio and Pulse platform will continue to support our innovation s…

The 10 largest orthopedic device companies in the world

Stryker, Johnson & Johnson’s DePuy Synthes and Zimmer Biomet top the list of largest orthopedic device companies. [Adobe Stock image]With elective procedure numbers rebounded after the darkest days of the COVID-19 pandemic, most of the world’s largest orthopedic device companies saw their revenues increase by double-digit percentages during their most recent fiscal years.

Here are the world’s 10 largest orthopedic device companies, ranked by ortho business revenue pulled from their most recent annual reports:

Largest orthopedic device companies Annual revenue (% change) Headquarters 1 Stryker $17.1 billion (+19.2%) Kalamazoo, Michigan 2 Johnson & Johnson – DePuy Synthes $8.6 billion (+10.6%) Locations: Raynham, Massachusetts.; West Chester, Pennsylvania; Warsaw, Indiana; Palm Beach Gardens, Florida 3 Zimmer Biomet (minus ZimVie spinoff) $6.8 billion (+11.6%) Warsaw, Indiana 4 Medtronic – Cranial & Spinal Technologies $4.5 billion (+3.9%) Locat…

NuVasive beats The Street in Q1, raises 2022 guidance

NuVasive (Nasdaq:NUVA) shares ticked up today on first-quarter results that came in ahead of the consensus forecast.

The San Diego-based company posted profits of $19.2 million, or 35¢ per share, on sales of $290.8 million for the three months ended March 31, 2022, for a massive bottom-line gain out of the red on sales growth of 7.2%.

Adjusted to exclude one-time items, earnings per share were 54¢, 15¢ ahead of Wall Street, where analysts were looking for sales of $290.8 million.

“I am pleased with our results during the first quarter, which exceeded our expectations,” NuVasive CEO Chris Barry said in a news release. “Despite COVID-19 and macro-economic pressure in the first half of the quarter, our performance reflects the strong health of our business and positions us well for continued growth. Looking ahead to the remainder of the year, we expect our novel technology to drive further differentiation with our surgeon partners. Led by the X360 and C360 sys…

NuVasive announces positive data for its Simplify cervical disc

NuVasive (Nasdaq:NUVA) today announced data from an FDA investigational device exemption study supporting its Simplify cervical disc.

San Diego-based NuVasive’s two-level FDA IDE study data was recently published in the Journal of Neurosurgery: Spine and utilized in the device’s FDA pre-market application for two-level indication approval, which NuVasive received in April 2021.

The peer-reviewed publication includes data demonstrating significantly greater success rate with the Simplify disc at the 24-month follow-up compared to anterior cervical discectomy and fusion (ACDF) when used for two-level cervical total disc replacement (cTDR), according to a news release.

Overall composite success rate was statistically significantly greater in the cTDR group compared to the ACDF group at 24 months. Mean Neck Disability Index scores improved in both groups, with the cTDR actually scoring lower at follow-up points, while neck and arm pain scores imp…

Nuvasive Attrax Putty wins FDA expanded clearance for use in thoracolumbar interbody procedures

Nuvasive today announced that its Attrax Putty received FDA 510(k) clearance for expanded indications in thoracolumbar interbody spine surgery.

Attrax Putty is a synthetic, bioactive and osteoconductive bone void filler that drives bone fusion. San Diego-based Nuvasive designed it with a surface microarchitecture that has an optimized environment for bone formation without added cells or growth factors.

The bone grafting device is supported by a level I randomized controlled trial as a bone graft substitute in posterolateral spinal fusions. Recent studies demonstrated that Attrax Putty performs comparably to autograft bone in thoracolumbar interbody fusions, according to Nuvasive.

“The expanded indications of Attrax Putty with thoracolumbar implants support the clinical efficacy of Attrax Putty and highlight the comparative clinical advantage over competitive biologic offerings in the market,” chief technology officer Ryan Donahoe said in a n…

Globus Medical could be eying NuVasive

Globus Medical (NYSE: GMED) has made an offer to acquire fellow spine surgery tech company NuVasive (Nasdaq:NUVA), according to Bloomberg and Reuters.

Both media outlets cited people familiar with the matter during their reports yesterday.

If it takes place, the deal would create one of the largest players in the spine space, with a 17% market share, according to Truist analysts Samuel Brodovsky and David Rescott.

“Within NuVasive’s portfolio, we see the Pulse system and Simplify Cervical Disc as being two of the company’s larger growth drivers over the next several years, and think that both could be attractive to Globus,” Brodovsky and Rescott said in a report posted after the Bloomberg news story.

However, the Truist analysts also thought the deal unlikely because Globus Medical has a track record of executing smaller transactions and growing organically.

“We think that large orthopedic integrations can be m…

NuVasive to launch virtual reality training platform for spine surgery

NuVasive (NSDQ:NUVA) announced today that it will release a virtual reality (VR) training module for its NuVasive X360 system.

San Diego-based NuVasive said in a news release that the launch of the cutting-edge training module complements its market-leading clinical professional development (CPD) program.

The NuVasive X360 VR training module — developed in collaboration with PrecisionOS — integrates NuVasive’s comprehensive lateral approach to single-position spine surgery, which includes XLIF, XALIF and XFixation, into a virtual simulation of the procedural workflow in an effort to offer remote access to hands-on learning experiences with the company’s surgical techniques.

“Our collaboration with PrecisionOS reiterates our long-standing commitment to surgeon training and education to help further the adoption of less invasive surgical procedures like X360,” NuVasive CCO Massimo Calafiore said in the release. “The integratio…

NuVasive launches newest porous PEEK implant for posterior spine surgery

NuVasive (NSDQ:NUVA) announced today that it launched the Cohere TLIF-O porous PEEK implant for posterior spine surgery.

San Diego-based NuVasive also confirmed a planned launch for its Cohere TLIF-A implant for later in the fourth quarter of this year. According to a news release, NuVasive is the only company to offer both porous PEEK and porous titanium implants for posterior spine surgery with the new additions to its advanced materials science portfolio.

Cohere TLIF-O, a porous PEEK implant for transforaminal lumbar interbody fusion (TLIF), features a proprietary porous surface technology to generate stronger integration through bony in-growth and on-growth, while its design with lordosis in the oblique plane helps to maintain coronal alignment while restoring sagittal balance.

The platform also features a radiolucent polymer composition to enable clear radiographic visualization of the fusion site with a variety of different imaging modalities.

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